title: Setting up a randomized clinical trial in the UK: approvals and process.
abstract: Randomized clinical trials are considered the 'gold standard' in primary research for healthcare interventions. However, they can be expensive and time-consuming to set up and require many approvals to be in place before they can begin. This paper outlines how to determine what approvals are required for a trial, the background of each approval and the process for obtaining them.
authors.affiliation: Dundee Dental Hospital and School, Dundee, UK. louise.greene@nhs.net
authors.forename: Louise Eleanor
authors.initials: LE
authors.lastname: Greene
authors.forename: David R
authors.initials: DR
authors.lastname: Bearn
mesh_terms: D002985:Clinical Protocols; D003219:Confidentiality; D016208:Databases, Factual; D018795:Device Approval / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research; D032984:Ethics, Research; D017408:Guidelines as Topic; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D009862:Online Systems; D017712:Peer Review, Research; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards; D012042:Registries; D012107:Research Design / Q000331:legislation & jurisprudence / Q000592:standards; D012637:Security Measures; D013222:State Medicine / Q000331:legislation & jurisprudence; D006113:United Kingdom
keywords: Clinical trials; ethics